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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 419588
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5086mri58 lead, implanted: (b)(6) 2013; 5086mri52 lead, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient had an infection.The cardiac resynchronization therapy defibrillator (crt-d) and leads were explanted and later replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN STARFIX LEAD
Common Device Name
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10582257
Report Number2649622-2020-18397
Device Sequence Number14210284
Product Code OJX
UDI-Device Identifier00643169590649
UDI-Public00643169590649
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P060039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date02/07/2021
Device Model Number419588
Device Catalogue Number419588
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/09/2020
Initial Report FDA Received Date09/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
693558 LEAD, DTMA1D1 CRT-D
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age74 YR
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